FDA Expedited Approvals of Expanded Cord Blood Products

As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
Parent's Guide to Cord Blood Foundation published a review of expanded cord blood products in May 2018.

Date	Expanded Cord Blood Product	Manufacturer	Indication	FDA Expedited Path(s)
20180717	NiCord®	Gamida Cell	HSCT: Hematopoietic Stem Cell Transplants	Breakthrough Therapy Orphan Drug
20180806	NLA101 Dilanubicel	Nohla Therapeutics	HSCT engraftment, Neutropenia	Orphan Drug Fast Track
20180823	Pneumostem®	Medipost	Bronchopulmonary Dysplasia	Orphan Drug Fast Track
20190423	ECT-001	ExCellThera	Hematologic Malignancies	Regenerative Medicine Advanced Therapy (RMAT)
20190904	MGTA-456	Magenta Therapeutics	Inherited Metabolic Disorders	Regenerative Medicine Advanced Therapy (RMAT)

Comments Disclaimer

These comments are submitted by website readers and are not endorsed by CellTrials.org, which is a project of Parent's Guide to Cord Blood Foundation. We screen the comments to keep out SPAM but we cannot review each one for accuracy.